VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
FDA 510(k) clearance K964310 · decided 1996-11-27
Clearance details
- K-number
- K964310
- Device name
- VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-29
- Decision date
- 1996-11-27
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- CDP
- Device class
- 2
- Regulation number
- 862.1710
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (K001607) | Repromedix Corp. | 2000-10-05 |
| CHIRON DIAGNOSTICS ACS: 180 FT3 (K991692) | Chiron Diagnostics Corp. | 1999-06-18 |
| TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (K991311) | Biocheck, Inc. | 1999-06-02 |
| AIA-PACK FT3 ASSAY (K991252) | Tosoh Medics, Inc. | 1999-05-11 |
| OPTICOAT T3 EIA KIT (K981824) | Biotecx Laboratories, Inc. | 1998-12-22 |
| ABBOTT ARCHITECT FREE T3 (K983439) | Abbott Laboratories | 1998-11-20 |
| ABBOTT ARCHITECT TOTAL T3 (K983434) | Abbott Laboratories | 1998-11-20 |
| AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (K974027) | Alfa Biotech (Uk) , Ltd. | 1998-02-02 |
| IMMULITE FREE T3 (K974634) | Diagnostic Products Corp. | 1998-01-02 |
| ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973966) | Beckman Instruments, Inc. | 1997-10-31 |
| TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (K971779) | Monobind | 1997-06-16 |
| DSL ACTIVE T3 EIA (K971270) | Diagnostic Systems Laboratories, Inc. | 1997-05-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Ident recall (Z-1707-2015) | ORTHO-CLINICAL DIAGNOSTICS | 2015-06-04 |
| VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diag recall (Z-0765-06) | Ortho-Clinical Diagnostics | 2006-04-20 |
| Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic us recall (Z-0558-03) | Ortho-Clinical Diagnostics | 2003-02-21 |